|
Prescription
Pediatric Cold Drug Recalled
Houston, TX., Feb.
5---Great Southern Laboratories, a Houston pharmaceutical
manufacturer, has issued a recall of all bottles of Cydec Drops, Lot
#02950, a prescription pediatric cold drug. The product is a
one-ounce bottle and calibrated dropper packaged in a carton, all
bearing Cypress Pharmaceutical Inc. labeling. More than 6,000
bottles were distributed to wholesalers for national distribution in
Dec. 2000.
The recall was issued by
Great Southern Laboratories upon learning the outer carton of the
Cydec Drops bottle bore an incorrect dosage chart. The chart
incorrectly equates a dropperful and partial dropperfuls to a
teaspoonful and partial teaspoonfuls. If a consumer uses the
incorrect chart to administer medicine with a teaspoon to a child,
an overdose could occur.
Overdoses of this
medication can cause serious illness or death, depending on the
number of factors including the health of the child and the extent
of the overdose. No reports of illness have been received.
The Food and Drug
Administration urges consumers in possession of Cydec Drops, lot
#02950, to discontinue use and return it to the pharmacist
immediately.
The product label bears
NDC #60258-439-30, with an expiration date of 12/2005. Each
one-ounce bottle contains 2 mg. of carbinoxamine maleate (an
antihistamine) and
25 mg. Pseudoephedrine
hydrochloride (a decongestant) in each 1 ml. of product.
For more information,
consumers may call Great Southern Laboratories toll free at
800-747-0783.
|
